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GAO-04-490 Antibiotic Resistance: Federal Agencies Need to Better

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GAO-04-490 Antibiotic Resistance: Federal Agencies Need to Better United States General Accounting Office GAO Report to Congressional Requesters April 2004 ANTIBIOTIC RESISTANCE Federal Agencies Need to Better Focus Efforts to Address Risk to Humans from Antibiotic Use in Animals a GAO-04-490 April 2004 ANTIBIOTIC RESISTANCE Federal Agencies Need to Better Focus Highlights of GAO-04-490, a report to Efforts to Address Risk to Humans from congressional requesters Antibiotic Use in Animals Antibiotic resistance is a growing Scientific evidence has shown that certain bacteria that are resistant to public health concern; antibiotics antibiotics are transferred from animals to humans through the consumption used in animals raised for human or handling of meat that contains antibiotic-resistant bacteria. However, consumption contributes to this researchers disagree about the extent of harm to human health from this problem. Three federal agencies transference. Many studies have found that the use of antibiotics in animals address this issue—the Department poses significant risks for human health, but a small number of studies of Health and Human Services’ (HHS) Food and Drug contend that the health risks of the transference are minimal. Administration (FDA) and Centers for Disease Control and Prevention Federal agencies have expanded their efforts to assess the extent of (CDC), and the Department of antibiotic resistance, but the effectiveness of their efforts to reduce human Agriculture (USDA). GAO health risk is not yet known. FDA, CDC, and USDA have increased their examined (1) scientific evidence on surveillance activities related to antibiotic resistance. In addition, FDA has the transference of antibiotic taken administrative action to prohibit the use of a fluroquinolone in poultry. resistance from animals to humans FDA has identified animal drugs that are critically important for human and extent of potential harm to health and begun reviewing currently approved drugs using a risk human health, (2) agencies’ efforts assessment framework that it recently issued for determining the human to assess and address these risks, health risks of animal antibiotics. However, because FDA’s initial reviews of (3) the types of data needed to approved animal drugs using this framework have focused on other drugs support research on these risks and extent to which the agencies and have taken at least 2 years, FDA’s reviews of critically important drugs collect these data, (4) use of may not be completed for some time. antibiotics in animals in the United States compared with its key Although federal agencies have made some progress in monitoring antibiotic agricultural trading partners and resistance, they lack important data on antibiotic use in animals to support competitors, and (5) information research on human health risks. These data, such as the type and quantity of on how use has affected trade. antibiotics and purpose for their use by species, are needed to determine the linkages between antibiotic use in animals and emerging resistant bacteria. In addition, these data can help assess human health risks from this use and GAO recommends that (1) FDA develop and evaluate strategies for mitigating resistance. expedite its risk assessments of drugs used in animals that are The United States and several of its key agricultural trading partners and critical for human health and competitors differ in their use of antibiotics in animals in two important (2) USDA and HHS develop and areas: the specific antibiotics allowed for growth promotion and availability implement a plan to collect data on of antibiotics to producers (by prescription or over the counter). For antibiotic use in animals. USDA example, the United States and Canada allow some antibiotics important in and HHS generally agreed with human medicine to be used for growth promotion, but the European Union GAO’s findings. With respect to the (EU) and New Zealand do not. Regarding over the counter sales of recommendations, HHS agreed that antibiotics, the United States is generally less restrictive than the EU. it is important to review animal drugs that are critical to human health and both agencies discussed Antibiotic use in animals has not yet been a significant factor affecting U.S. ways to better collect antibiotic use international trade in meat and poultry, although the presence of antibiotic data. residues in meat has had some impact, according to government and industry officials. Instead, countries raise other food safety issues, such as www.gao.gov/cgi-bin/getrpt?GAO-04-490. hormone use and animal diseases. However, according to these officials, To view the full product, including the scope antibiotic use in animals may emerge as a factor in the future. They and methodology, click on the link above. particularly noted that the EU could object to U.S. use of antibiotics for For more information, contact Anu Mittal at growth promotion as its member countries are phasing out that use. (202) 512-3841 or Marcia Crosse at (202) 512-7119. Contents Letter 1 Results in Brief 6 Background 8 Antibiotic-Resistant Bacteria Have Been Transferred from Animals to Humans, but Researchers Disagree About the Extent of Potential Harm to Human Health 17 Federal Agencies Have Increased Surveillance of Antibiotic Resistance from Animals to Assess Human Health Risk; Effectiveness of Risk Reduction Efforts Is Not Yet Known 27 Federal Agencies Do Not Collect Data Needed to Address the Risk of Antibiotic Resistance Associated with Use in Animals 39 The United States and Its Key Trading Partners and Competitors Differ in the Restrictions They Place on the Use of Antibiotics in Animals 43 Antibiotic Use in Animals Has Not Significantly Affected U.S. Trade but Could Be an Issue in the Future 45 Conclusions 47 Recommendations for Executive Action 48 Agency Comments and Our Response 49 Appendixes Appendix I: Objectives, Scope, and Methodology 52 Appendix II: Studies of the Economic Impacts of Restricting Antibiotic Uses in Animals 57 Appendix III: FDA’s Procedures for Evaluating the Importance of an Animal Drug for Human Health 72 Appendix IV: Information on Selected Countries’ Activities to Address Animal-Related Antibiotic Resistance 73 Appendix V: Antibiotics Frequently Used in Animals 80 Antibiotic Use in U.S. Feedlot Cattle Production 80 Antibiotic Use in U.S. Swine Production 81 Antibiotic Use in U.S. Broiler Production 82 Appendix VI: Comments from the U.S. Department of Agriculture 84 GAO’s Responses to USDA’s Comments 87 Appendix VII: Comments from the Department of Health and Human Services 88 Page i GAO-04-490 Antibiotic Use in Animals Contents Appendix VIII: GAO Contacts and Staff Acknowledgments 95 GAO Contacts 95 Acknowledgments 95 Tables Table 1: Federal Surveillance Activities Related to Antibiotic Resistance and Foodborne Disease or Animal Health 28 Table 2: Economic Studies That Estimate the Effects of Restrictions on Antibiotic Use 58 Table 3: Antibiotic Sales and Meat Production, 2002 73 Table 4: Antibiotics Frequently Used in Feedlot Cattle, 1999 81 Table 5: Antibiotics Frequently Used in Swine, 2000 82 Table 6: Antibiotics Frequently Used in Feed for Broiler Chickens, 1995-2000 83 Figures Figure 1: Swine Confinement Facility 11 Figure 2: Possible Spread of Antibiotic-Resistant Bacteria from Animals to Humans 12 Figure 3: Sources of Data from Surveillance Activities about Antibiotic Resistance and Foodborne Disease or Animal Health 29 Page ii GAO-04-490 Antibiotic Use in Animals Contents Abbreviations ADG average daily weight gain ADP antibiotics used for disease prevention AGP antibiotics used for growth promotion CAHFSE Collaboration in Animal Health, Food Safety, and Epidemiology CDC Centers for Disease Control and Prevention DT definitive type DNA deoxyribonucleic acid EU European Union FAO Food and Agriculture Organization of the United Nations FAS Foreign Agricultural Service FCR feed conversion ratio FDA Food and Drug Administration FoodNet Foodborne Diseases Active Surveillance Network HIV human immunodeficiency virus HHS Department of Health and Human Services MR mortality rate NAHMS National Animal Health Monitoring System NARMS National Antimicrobial Resistance Monitoring System—Enteric Bacteria NRC National Research Council OIE Office International des Epizooties Q/D quinupristin/dalfopristin USDA U.S. Department of Agriculture WHO World Health Organization WTO World Trade Organization This is a work of the U.S. government and is not subject to copyright protection in the United States. It may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately. Page iii GAO-04-490 Antibiotic Use in Animals A United States General Accounting Office Washington, D.C. 20548 April 22, 2004 Leter The Honorable Olympia J. Snowe Chair, Committee on Small Business and Entrepreneurship United States Senate The Honorable Tom Harkin Ranking Democratic Member Committee on Agriculture, Nutrition, and Forestry United States Senate The Honorable Edward M. Kennedy Ranking Minority Member Committee on Health, Education, Labor, and Pensions United States Senate Antibiotic resistance is a serious and growing public health problem.1 As resistance to antibiotics develops in disease-producing bacteria, it can become difficult to treat diseases that were formerly treatable with antibiotics, and this can have deadly consequences. Treating antibiotic- resistant
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